Siemens Dade PFA Collagen/ EPI and Dade PFA Collagen/ ADP Test Cartridges - HSA Registration DE0508470
Access comprehensive regulatory information for Siemens Dade PFA Collagen/ EPI and Dade PFA Collagen/ ADP Test Cartridges in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0508470 and owned by Siemens Healthcare Diagnostics Products GmbH. The device was registered on September 11, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Dade PFA Collagen/ EPI Test Cartridge and Dade PFA Collagen/ ADP Test Cartridge are in vitro diagnostic reagents for the quantitative determination of the collagen/epinephrine- and collagen/ADP-induced PFA closure times. The assays can be used as aid to diagnosis and follow up of congenital, acquired or therapy induced defects of primary hemostasis, including von Willebrand factor (vWF) dependent deficiencies, in patients at risk for or suspected of impaired primary hemostasis. The assays are performed using human sodium citrated whole blood by means of an automated, platelet adhesion and aggregation method under flow conditions.